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Pilot Study for ctDNA Detection in Hepatobiliary and Pancreatic Cancers

This pilot study is investigating if collecting blood from a cancer-draining vein (the vein directly connected to the tumor) can improve the detection of circulating tumor DNA (ctDNA) compared to a standard blood draw from a peripheral vein (like in your arm). ctDNA is genetic material from cancer cells found in the blood. This study is for people aged 18 or older who have or are being evaluated for hepatobiliary (liver and bile duct) or pancreatic cancers, such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, or pancreatic carcinoma, and are scheduled for a biopsy. The main goal is to compare the amount of ctDNA found in samples from both types of blood draws. The study is currently unclear on its recruitment status.

Study design
This is a single-center pilot study with a planned enrollment of 15 participants. It is an interventional study, but the phase is not specified.
What's involved
You would have blood collected from a peripheral vein and a cancer-draining vein during your scheduled biopsy. The study will measure ctDNA levels for up to 1 year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 1 year to compare ctDNA levels.

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NCT05497531

Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

Recruiting
NAAges 18+InterventionalDiagnostic
University of California, Irvine
~15 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:ctDNA Blood Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
Measured over Up to 1 year

Conditions

Hepatobiliary Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Ampullary Cancer
Pancreatic Carcinoma

Explore related trials

Ampullary CancerCholangiocarcinomaHepatobiliary CancerHepatocellular CarcinomaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Nadine Abi-Jaoudeh, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-7883
Email the study team

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Eligibility criteria

Inclusion

18 years of age or older
Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
Must be able to provide a written informed consent

Exclusion

Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
Patients with uncorrectable coagulopathy
Platelet count \< 30,000/ul
International Normalized (INR) \> 1.5
Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
No clear reachable target for percutaneous or trans-jugular biopsy
Patient who cannot have a peripheral blood draw for ctDNA

What this trial measures

  • Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequencyUp to 1 year

    Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples